Skin and Soft Tissue Substitutes for Diabetic Foot Ulcers and Venous Leg Ulcers

This policy covers use of skin and soft tissue substitutes (cellular and tissue‑based products/CTPs) for treatment of diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), and chronic wounds as part of a wound‑care treatment plan when the requested use complies with the product's FDA‑labeled indications and the policy's clinical criteria. Coverage is limited to non‑infected wounds that have failed to heal or shown stalled healing (e.g., <50% area reduction after ≥4 weeks of compliant standard‑of‑care including debridement, offloading for DFUs or sustained compression for VLUs, infection control and management of comorbidities), is restricted to designated preferred products, allows up to four initial applications per wound (with authorization for up to eight total applications if criteria are met), and requires thorough documentation; burns and Medicare plans are excluded.

"Use of skin substitute grafts for treatment of diabetic foot ulcers."